Methods and devices for reducing lumen constriction

ABSTRACT

A method and device for reducing constriction of the lumen of a tubular organ during healing subsequent to an operation. A device such as an implant is introduced into a tubular organ at least at the region thereof where surgical procedures are performed with the implant being capable of supporting the tubular organ at this latter region in such a way that it will prevent the tubular organ from becoming constricted due to compressive forces resulting from the formation of scar tissue. Preferably the implant extends along the interior of the tubular organ not only at the region where scar tissue forms but also in opposite directions beyond this region with the implant having a construction which will permit pumping action of the tubular organ to continue while the tubular organ is supported to oppose the action by the scar tissue which tends to contract the tubular organ.

United States Patent Bucalo [75] Inventor: Louis Bucalo, Holbrook, N.Y.

Investors 1n Ventures. Inc., New York, NY.

221 Filed: Dec. 17, 1973 21 Appl. No.: 424,927

[73] Assignee:

[52] U.S. Cl 128/1 R; 3/1; 3/D1G. 1; 128/334 R; 285/115 [51] Int. ClA61b 19/00 [58] Field of Search 128/1 R, 334 R, 334 C, 128/348, 350,374, 303 R; 3/1, DIG. 1; 285/103, 115, 116; 138/103, 118

[56] References Cited UNITED STATES PATENTS 1,928,992 10/1933 Clark etal. 138/103 3,155,095 11/1964 Brown 128/334 C 3,182,662 5/1965 Shirodkar128/303 R 3,221,746 12/1965 Noble 128/334 R 3,357,432 12/1967 Sparks...128/334 C 3,613,661 10/1971 Shah 128/334 R OTHER PU BLlCATlONSAllansmith, Jour. Thorac. Surg., Vol. 44, No. 2, August 1962, pp 258263.

14 1 May 13, 1975 Primary E.\'aminerDalton L. Truluck Attorney, Agent,or Firm-Steinberg & Blake 1 1 ABSTRACT A method and device for reducingconstriction of the lumen of a tubular organ during healing subsequentto an operation. A device such as an implant is introduced into atubular organ at least at the region thereof where surgical proceduresare performed with the implant being capable of supporting the tubularorgan at this latter region in such a way that it will prevent thetubular organ from becoming constricted due to compressive forcesresulting from the formation of scar tissue. Preferably the implantextends along the interior of the tubular organ not only at the regionwhere scar tissue forms but also in opposite directions beyond thisregion with the implant having a construction which will permit pumpingaction of the tubular organ to continue while the tubular organ issupported to oppose the action by the scar tissue which tends tocontract the tubular organ.

24 Claims, 27 Drawing Figures SCAE 775.5'UE REG/ON METHODS AND DEVICESFOR REDUCING LUMEN CONSTRICTION BACKGROUND OF THE INVENTION The presentinvention relates to implanting methods and implants capable of reducingconstriction of a tubular organ of a living being as a result of theformation of scar tissue.

As is well known, when an implant is to be intro duced into a tubularorgan of a living being such as a human being, surgical procedures arenecessarily performed at the region of the tubular organ so as toprovide access to the interior thereof. After obtaining this access tothe interior of the tubular organ, an implant is conventionallyintroduced into the tubular organ, and then surgical procedures areperformed in order to close the incision or the like which is formed inorder to have access to the interior of the tubular organ. As a resultof these surgical procedures scar tissue or fibroblasts will form duringthe healing process. It has been found that such scar tissue will exertcompressive forces on the tubular organ which may tend to contact thetubular organ so that the interior volume thereof becomes constricted.

Thus, it is essential to carry out the surgical procedures in connectionwith introducing the implant into the tubular organ at a given regionwhich extends through a given distance along the tubular organ, and

- along this latter distance the scar tissue will form, generatingforces which are directed inwardly toward the lumen for reducing theinterior cross section of the tubular organ, sometimes to such an extentthat it becomes completely closed. In the event that the implant isshorter than the region along which the scar tissue grows, the tubularorgan may becoome closed or nearly closed at a region upstream ordownstream or both upstream and downstream of the implant.

The above problem is encountered at various parts of the body wheretubular organs are situated. For example one type of implant is a vasvalue to be introduced into a vas deferens for reversibly interruptingthe flow of sperm-carrying fluid therethrough. If the implant in thiscase does not extend along the interior of the vas throughout and beyondthe range where scar tissue forms along the exterior of the vas, the vaswill become constricted due to the formation of the scar tissue to suchan extent that even when the vas valve is open an inadequate flow ofsperm-carrying fluid will result.

A further example of regions where the above problem is encountered isin connection with tubular body conduits such as blood vessels. Thus, itis known that in connection with surgical procedures or wounds resulting from injuries or the like it is necessary to splice separatedportions of such a conduit together. This procedure may conventionallybe performed by connecting the severed ends of a body conduit togetherwhile situating in the interior of the conduit a tubular structure whichextends across the severed ends which are surgically connected to eachother. In this case also where the implant does not extend through andbeyond the region where scar tissue subsequently grows, the body conduitwill become undesirably consticted as a result of the formation of thescar tissue, and the flow of body fluid will be undesirably constricted,creating problems similar to those which are encountered in connectionwith various types of sclerosis such as arteriosclerosis andarteriolosclerosis.

SUMMARY OF THE INVENTION It is accordingly a primary object of thepresent invention to provide an implanting method and implant whch willavoid these problems.

In particular, it is an object of the present invention to provide animplanting method and implant capable of supporting a tubular organ atthe interior thereof in such a way that the tubular organ will notbecome undesirably constricted due to formation of scar tissue.

Also it is an object of the present invention to provide an implantingmethod and implant which will prevent kinking of a tubular organ so thatflow of a fluid therethrough will not be prevented by kinks which mightotherwise form.

In addition it is an object of the present invention to provide animplanting method and implant which will enable a tubular organ tocontinue to carry out its normal pumping action such as a peristalticaction, while at the same time the tubular organ is supported at itsinterior in such a way that it will not become undesirably constrictedby the formation of scar tissue.

Yet another object of the present invention is to provide in the case ofvas valve implants, a method and apparatus for reliably preventing anypossibilityof sperm bypassing the valve along the exterior thereof.

When surgical procedures are performed such as in connection withintroduction of an implant into a tubular organ, there is a region alongthe exterior of the tubular organ where scar tissue will grow duringhealing. According to the invention the implant has a lengthsufficiently great to enable it to extend through and be yond the regionof the tubular organ where scar tissue forms at the exterior of thelatter, with the implant being capable of supporting the tubular organin such a way that it will not become constricted due to the formationof scar tissue.

The implant of the invention preferably extends not only along theinterior of the tubular organ at an operative region where scar tissueforms, but also in opposite directions beyond the operative region intononoperative regions of the tubular organ where scar tissue does notgrow, the implant having a pair of elongated flexible means which extendin opposite directions into the latter non-operative regions in such away that these regions connot kink but instead remain flexible and arecapable of contracting and expanding to perform a pumping action such asa peristaltic action, so that kinking of the tubular organ is preventedand constriction due to formation of scar tissue is also avoided.

BRIEF DESCRIPTION OF DRAWINGS The invention is illustrated by way ofexample in the accompanying drawings which form part of this applicationand in which:

FIG. 1 is a schematic illustration of the problem which is solved by thepresent invention;

FIG. 2 schematically illustrates a solution to the problem with themethod and implant of the invention;

FIG. 3 illustrates a specific type of solution to the problem, inaccordance with the invention;

FIG. 4 is a schematic longitudinal sectional elevation of a specific vasvalve implant and implanting method of the invention, including a spermbarrier;

FIGS. 57 are respectively transverse sections taken along lines 5-5, 66,and 77 of FIG. 4 in the direction of the arrows;

FIG. 8 illustrates how an arrangment as shown in FIG. 6, for example,enables the pumping action to continue;

FIGS. 9-12 respectively illustrate different possible embodiments ofelongated means which may be used with and form part of implants of theinvention, to carry out the method of the invention;

FIG. 13 is a fragmentary schematic longitudinal sectional illustrationof yet another embodiment of a method and implant of the invention;

FIG. 14 is a transverse section taken along line l414 of FIG. 13 in thedirection of the arrows;

FIGS. 15-21 respectively illustrate various embodiments of theinvention, in connection with tubular organ implants, in schematiclongitudinal sectional elevations;

FIG. 22 is a longitudinal schematic sectional elevation of yet anotherembodiment where structure is placed around the exterior of the tubularorgan;

FIG. 23 shows yet another embodiment of the invention where a temporarysupport is provided to oppose constriction of the tubular organ;

FIG. 24 illustrates a further embodiment of the invention where acluster of dissolvable particles oppose constriction of a lumen;

FIG. 25 is a schematic illustration of a method according to which it ispossible to manufacture a further embodiment of an implant according tothe invention;

FIG. 26 illustrates the implant resulting from the method of manufactureshown in FIG. 25 situated in a tubular body organ; and

FIG. 27 is a schematic fragmentary illustration of a sperm barrierutilized with vas valve implants and implanting methods according to theinvention.

DESCRIPTION OF PREFERRED EMBODIMENTS Referring to FIG. 1, the problemsolved by the present invention is illustrated therein. Thus, FIG. 1schematically illustrates part of an elongated tubular body organ 20.This tubular body organ may be a vas deferens, a blood vessel or anytubular body conduit for conveying a body fluid. It is assumed that animplant 22 is to be situated in the tubular organ in the mannerillustrated schematically in FIG. 1 which shows the previously formedincision closed at 23. This implant 22 will have a tubular constructionenabling a body fluid to flow through the organ 20 after the implant 22is introduced. Thus in the case of a vas deferens, the implant 22 mayhave a valve structure for reversibly interrupting the flow ofsperm-carrying fluid, or in the case of a blood vessel which has beenruptured or severed for any reason, the implant 22 will be in the formof a simple splicing tube situated in the interior of the organ 20extending across the parts of the tubular organ 20 which are connectedtogether. The implant has at its exterior a means for promoting theingrowth of tissue.

In any case, in order to introduce the implant 22, surgical procedureswill be performed at the region 24 of the body tissue which surroundsthe tubular organ 20 and which is indicated by the dot-dash line. Thisregion 24 may be considered an operating or operative region where anincision is formed so as to give access to the interior of the tubularorgan 20. It is in this region 24 that scar tissue forms during healingof the tissue surrounding the tubular organ 20 after the implant 22 hasbeen introduced. As may be seen from FIG. 1, the incision area 24 wherescar tissue forms extends beyond the ends of the implant 22. Thus, afterthe incision is made and closed subsequent to the introduction of theimplant 22 into the tubular organ 20, the tissue heals at the region 24.During healing the tissue swells and fibroblast growth takes placeduring healing. This fibroblast or scar tissue is very tough and growsrapidly. Upon healing, the scar tissue presses radially inwardly againstthe wall of the tubular organ 20, as indicated by the arrows 26, causingconstriction and collapse of the wall of the tubular organ 20,particularly at locations just beyond the ends of the implant 22. Thus,this radial inwardly directed pressure resulting from the formation ofthe scar tissue may close and seal the tubular organ 20 for a periodwhich may last for many months and even years. In the case of a vasdeferens, such unforeseen closure thereof may go unnoticed for such along period of time, whereas in the case of a blood vessel, anyappreciable constriction of this type will create serious problems suchas those encountered with sclerosis conditions.

Referring now to FIG. 2, the principles of the present invention areillustrated therein. Thus, FIG. 2 shows an elongated body organ 20 whichmay be the same as that illustrated in FIG. 1. FIG. 2 also shows theregion 24 which may be considered the surgical or operative area,whereas non-surgical regions are indicated beyond the region 24 wherethe scar tissue grows. FIG. 2 also illustrates an implant 27 replacingimplant 22 shown in FIG. 1.

According to the invention the implant 27 has connected thereto a pairof elongated means 28 which extend in opposite directions from theintermediate part of the implant which is designed to perform a specificfunction such as reversibly interrupting the flow of sperm-carryingfluid or forming a splice between severed portions of a blood vessel.The pair of elongated means 28 which thus form implant extensions aresufficiently long to extend beyond the area 24 into the nonsurgicalareas 30 where scar tissue does not grow. These elongated means 28 mayhave any one of several constructions referred to in detail below,according to which they are capable of supporting the tubular organ 20in the interior such a way that inward constriction of the tubular organcannot occur in the manner described above in connection with FIG. 1.

A specific example of the present invention which has been used inpractice is illustrated in FIG. 3. In FIG. 3 the tubular organ 20 is avas deferens which in the illustrated example receives a two-piece vasvalve 32 through incision 35. This two-piece vas valve has a leftsection 34 joined to a right section 36, as viewed in FIG. 3. One of theadvantages of the two-piece vas valve 32 is that the incision requiredfor such a vas valve can be made extremely small so that the surgicalarea 38 in the case of FIG. 3 is limited as compared to conventionalsurgical areas in connection with gaining access to the interior of atubular organ. Thus, because the valve 32 is made in the separatesections 34,36, an extremely short incision will enable the separatesections 34 and 36, to be independently introduced while they areseparate from each other, and thereafter they can be joined together. Inthis way the extent to which the surgical operations must extendlongitudinally along the tubular organ is reduced, and the length of thesections 34 and 36 after they are joined to each other is such that theassembled vas valve 32 extends throughout the region 38 and beyond thelatter into the non-surgical areas 40 where the opposed free end regionsof the sections 34 and 36 are situated in areas of the tubular organ 20which are free of the trauma resulting from the surgical procedures atthe region 38. Actual experience with this type of implant hasdemonstrated that immediately after introduction of the implant, when itis maintained open until healing is completed, and throughout thehealing period, a full uninterrrupted flow of sperm-carrying fluid ismaintained, as demonstrated by actual sperm counts taken under the aboveconditions. In contrast, with an arrangement as shown in FIG. 1 wherethe implant 22 is in the form of a vas valve, the sperm count is greatlyreduced as compared to that which is acheived with the arrangement ofFIG. 3, demonstrating that the scar tissue substantially restricts thetubular organ 20 at the regions thereof located just beyond the implant22. Thus, by resorting to the implanting method and implant of theinvention, as demonstrated in FIG. 2 for a general case, it is possibleto avoid the above problems.

Referring to FIG. 4, a specific application of the present invention isillustrated therein. Thus, FIG. 4 shows a pair of sections 42 of a vaswhich has been cut through between these sections so as to receive theimplant 44 which in the illustrated example is a vas valve havingintermediate its ends the valve assembly 46 capable of opening andclosing the elongated tubular means 48 which is rigid and which extendsinto the lumen of the sections 42 in the manner illustratedschematically in FIG. 4. This structure carries at its exterior atissue-ingrowth means 50 for promoting the ingrowth of tissue at theexterior of the elongated tubular means 48. In accordance with thefeatures of the present invention the space between the vas sections 42is filled with a barrier means 200 surrounding and covering the part ofthe valve assembly 46 which is situated in this space. The barrier means200 is in the form of any jelly or other relatively thick highly viscoussubstance such as a medical silicone paste. Thus if it should happenthat any sperm should travel along the exterior of the implant and reachthe space between the vas sections 42, such sperm will be incapable oftravelling through the space between the vas sections 42 from one ofthese sections to the other because the thick paste or jelly which formsthe barrier means 200 will present the sperm an obstacle through whichthe sperm cannot travel. In this way bypassing of the valve by sperm isreliably avoided.

In accordance with the invention, a pair of elongated means 52 areconnected with the tubular means 48 at the opposed end regions thereof.These elongated means 52 may have a press fit into the interior of thetubular means 48. As is apparent from FIGS. 57, the elongated meansextending from each end of the tubu lar means 48 has a central region 54extending along the axis of the lumen and a plurality of ribs 56projecting radially from the central region 54. Each elongated means 52is made ofa flexible plastic material compatible with human tissue.Thus, in the illustrated example each elongated means 52 has the crosssection of a cross. The ribs 56 terminate in outer edge regions whichextend along the inner surface of the tubular organ 42. Moreover, as isapparent from a comparison of FIGS. 5-7 and as is illustrated in FIG. 4,each elongated means 52 tapers so as to terminate in a small tipsituated distant from the tubular-means 48. As a result of the use ofsuch elongated means 52, the tubular organ 42 will be supported at itsinterior against constriction resulting from growth of scar tissue,inasmuch as the total length of the implant, between the outer tips ofthe elongated means 52, is considerably longer than the region wherescar tissue will grow, this region being occupied at least partly by therigid tubular means 48. Because of the flexibility of the elongatedmeans 52, the tubular organ can bend without kinking, so that it cannotbecome closed by kinking. At the same time, the elongated means 52 has astrength sufficient to prevent inward constriction of the tubular organat those parts thereof where scar tissue grows and where the thickerparts of the elongated means 52 are located at the region of the ends ofthe tubular means 48.

Moreover, it will be noted that free hollow spaces are left in theinterior of the tubular organ on opposite sides of each of the ribs.This is a further important feature of the invention as may be seen froma comparison of FIGS. 6 and 8. A tubular organ such as a vas deferens orother tubular organs function to pump a body liquid along the interiorof the tubular organ by an action such as a peristaltic action duringwhich the tubular organ forms contractions which move longitudinallyalong the tubular organ. Because of the construction of the elongatedmeans 52 it is possible for tubular organ to contract into the spacesbetween the ribs 56, assum ing a configuration as illustratedschematically in FIG. 8, and thus the pumping action can proceed so thatthe body fluid can be pumped even though the tubular organ is supportedat its interior against undesirable constriction from the growth of scartissue. Thus, FIG. 6 may be considered as showing the tubular organ in asubstantially open condition while FIG. 8 may be considered as showing aperistaltic constriction which the organ assumes for carrying out apumping action.

The above-described configuration of the elongated means 52 is highlydesirable but is not essential. Thus, FIG. 9 shows an elongated means 60of V-shaped configuration situated in a tubular organ 62. FIG. 10 showsan elongated means 64 in the form of a simple strip having only a pairof opposed edge regions next to the inner surface of the tubular organ66. FIG. 11 shows an elongated means 68 also made of a flexible plasticsheet material and having a substantially U-shaped cross section so thatwhile it supports the tubular organ 70 against contraction from scartissue nevertheless the flexiblity of the elongated means 68 permits apumping action to take place as described above. FIG. 12 shows anelongated means 72 also made of a flexible plastic material, as is thecase with the above embodiments of the elongated means of the invention,but in this case the elongated means 72 is of a spiral-shaped crosssection. Thus, the tubular organ 74 will also be prevented by such aconstruction from collapsing due to the inward radial pressure of scartissue while at the same time it is possible for the elongated means 72to yield and expand as a result of peristaltic action or the like. Anyof the embodiments of FIGS. 9-12 may be substituted for that of FIGS.5-8 and connected in the same way to tubular valve portions 48.

A further possible embodiment of the invention is illustrated in FIGS.13 and 14 where a tubular means 76 corresponding to any of the tubularmeans described above is shown in a tubular organ 78. This tubular means76 fixedly carries at its interior in the region of its opposed ends aring 80 fixed to free ends of elongated extremely fine filaments orwires 82 which project freely beyond the tubular means 76 at each of theends thereof, only one of these ends being shown in FIG. 13. The extentto which the bundle of filaments or wires 82, which are flexible, extendbeyond the tubular means 76 at each of the ends thereof is sufficient tolocate these filaments or wires well beyond the region where scar tissuewill grow. Only a small number of filaments 82 are shown for the sake ofclarity. Such bundles of filaments or wires are capable of movinginwardly toward each other and spreading apart from each other so thatthey also will prevent constriction due to scar tissue while at the sametime enabling traveling contractions to occur in connection with thepumping action.

In connection with FIGS. 13 and 14, the filaments 82 may be heldtogether in any suitable way if necessary to facilitate insertionthereof. Thus, the surgeon may hold the filaments together with afinger. However, if desired, the filaments may be embedded in a body ofgelatin which dissolves subsequent to insertion. Also the filaments 82may be made of the same material as known dissolving sutures so thatafter healing is com pleted the filaments will be absorbed and entirelydisappear.

Referring to FIG. 15, the implant illustrated therein in the tubularbody organ which may be the vas deferens is in the form of an elongatedvalve means 84 having a central valve section 86 and a pair of elongated tubular portions 88 respectively extending in opposite directionsfrom the central valve section 86 through the area 90 where scar tissuesubsequently grows into the areas 92 where scar tissue does not grow.These elongated tubular portions 88 each have next to the central valvesection 86 a section 94 which is flexible so that in this way kinking ofthe tubular organ will be avoided, while beyond these flexible sections94 each tubular portion 88 has a section 96 carrying a tissue-ingrowthmeans 98 such as a suitable wire wound around the cylindrical free endportion 96 which extends into the area where scar tissue does not grow.The flexible portions 94 are fully capable of opposing constriction dueto formation of scar tissue. They are formed by circular convolutions sothat each section 94 has a construction similar to a bellows and whilemade of metal is nevertheless thin enough to flex to prevent kinking.The material used for the tubular portion as well as the remainder ofthe valve is any material compatible with the human body, such as gold,for example.

After obtaining access to the interior of a tubular body organ for anyreason, an implant of the invention, illustrated in FIG. 16, forexample, may be introduced only to prevent constriction of the lumen. Inthe embodiment of FIG. 16 the elongated implant 100 has a singleelongated continuous tubular portion 102 which is flexible along itsentire length and formed of convolutions so as to have the bellows-typeof construction referred to above in connection with sections 94. Inthis case the entire exterior surface of the elongated flexible tube 102carries the tissue-ingrowth means 104 which may be in the form ofasuitable filament wound around the tube 102 as illustrated in FIG. 16.

FIG. 17 shows an embodiment of the invention where the control meansformed by the implant is not a valve (FIGS. 3, 4, and 15) or a tube(FIG. 16) but instead has a central control region 106 to act on thefluid differently in different positions, as shown, for example, in U.S.Pat. No. 3,742,933. However, in this case the elongated tubular portions108 which are of constant diameter and which are substantially rigid arelocated next to the central control region 106 and carry thetissue-growth means 1 12 while beyond these portions 108 the elongatedtubular portions are each provided with the flexible bellows-type ofconstruction 114 according to which the circular convolutions arearranged as illustrated.

With the embodiment of FIG. 18 the central control means 106 is shown ina position different from FIG. 17 and the elongated tubular portions 120carry the tissue ingrowth means 122 so that except for the convolutedouter free end portions 114 the embodiment of FIG. 18 is identical withthat of FIG. 17. According to FIG. 18 a pair of elongated coil springs124 are pressed at their inner ends onto free ends of the portions 120so that these coil springs, also made of any suitable wire which iscompatible with the human body, such as gold wire, for example, willpermit the tubular organ to flex, thus avoiding kinking thereof, whileat the same time these coil springs are capable of opposing any tendencyfor the organ to become constricted due to formation of scar tissue.

In the embodiment of FIGS. 17 and 18, the central control region 106 hasits rotary body formed with a through-bore 117 which extends along theaxis of the body 110 and with a U-bore 118 which bypasses the bore 117.In the position of FIG. 17 the V-bore 118 provides communication betweenthe tubular portions 108 while the bore 117 is closed. In the positionof FIG. 18 the bore 117 provides communication between the tubularportions 120 while the V-bore 118 is closed. These bores 117 and 118 maycarry at their surfaces suitable chemicals or other deposits for actingon the body fluid in any desirable manner, or only one of the bores mayhave such a coating at its inner surface while the other bore isuncoated. In this way without acting to regulate the fluid flow in anyway it is possible to influence the body fluid in different ways.

According to the embodiments of the invention which is illustrated inFIG. 19, the control means formed by implant 124 is also in the form ofa valve means or other means for acting on the body fluid and adapted tobe introduced into a tubular organ, as illustrated. In this case alsothe control means 124 has the central control region 126 and the pair ofsubstantially rigid elongated tubular portions 128 respectively carryingthe tissue ingrowth means 130 and extending along the region where scartissue will normally grow. However, in this case the walls which formtubular portions 128 extend along the entire length of the implantbetween the opposed ends thereof but beyond the region which carries thetissue ingrowth means 130. Where these walls extend beyond the scartissue region they have been cut through with a suitable tool along aspiral path so as to form in this way elongated spring extensions 132which are integral with and extend from the solid wall sections 128.These sections 132 will perform in the same way as the springs 122described above in connection with FIG. 18.

FIG. illustrates an embodiment of the invention where in the illustratedtubular body organ 20 there is introduced an implant in the form of acontrol means 134 having the central control region 136 and the pair ofelongated tubular portions 138 respectively extending in oppositedirections from the central valve sections 136 and carrying the tissueingrowth means 140. According to this embodiment a pair of elongated cylindrical highly porous cylinders 142 of a material such as that usedfor dissolving sutures are intially situated in the interior of thetubular portions 138 and extend freely beyond the latter through adistance as illustrated in FIG. 20. These cylinders 142 do notappreciably oppose the flow of a body fluid and are capable also ofsupporting the tubular organ 20 against constriction during healing butat the same time they are capable of being absorbed into the systemwhile they dissolve so that eventually they will disappear leavingsubsequent to complete healing only the valve means 134 without theplugs 142. In this way also it is possible to oppose constriction due toformation of scar tissue while leaving the tubular organ in its initialcondition except for the implant 34.

In the embodiment of the invention which is illustrated in FIG. 21 thereis a control means 134 identical with the control means 134 of FIG. 20and carrying the tissue ingrowth means 140 in exactly the same way atthe tubular portions 138. However, in this case instead of cylinders142, elongated tapered convoluted tubular extensions 144 are provided.These extensions have inner cylindrical hollow portions 146 which arereceived in the interior of the portions 138 as illustrated. Thesetapered portions 144 which thus also have the circular convolutionsforming a bellows type of construciton will provide the required flexingto prevent kinking but at the same time opposing any tendency ofconstruction due to formation of scar tissue.

According to the embodiment of the invention which is illustrated inFIG. 22, the control means 148 is also shown as situated in a tubularbody organ 150 extending between the parts thereof into which thetubular portions 152 of the control means extend as illustrated. Thesetubular portions carry the tissue-ingrowth means 154 in the form of aporous matrix or of a wire, for ex ample, wound around the exterior ofthe tubular portions 152. These portions 152 extend through and beyondthe area where scar tissue will form so as to oppose any tendency forconstriction to take place. However, with this embodiment after theimplant is introduced the surgeon will wind a springy wire 156 of gold,platinum, or other material which is compatible with the human bodyaround the exterior of the vas 150 so as to achieve a construction asillustrated in FIG. 22. With this located the springs 156 form a meanslocated around the exterior of the tubular organ to permit the latter toflex without kinking. According to the embodiment of the invention whichis illustrated in FIG. 23, any tubular organ 160, such as any bloodvessel, for example, may be repaired as by having a severed portioninterconnected through the sutures 162. However, prior tointerconnecting the severcd portions of the tubular organ 160 theelongated implant 164 is introduced. This implant 164 in this case isformed in its en tirety of an elongated cylindrical tube of a materialcapable of being dissolved and absorbed into the system such as thematerial used for dissolving sutures. Thus the elongated tube 164 isintroduced into the tubular organ so that it will assume a position asindicated in FIG. 23. With this construction the tubular organ willresume its initial condition after healing with the entire implant 164disappearing completely. It is to be noted that the elongated tube 164will support the tubular organ against constriction while permitting therequired body fluid to flow through.

Of course, as was pointed out above in connection with FIGS. 13 and 14,the filaments 82 may be situated in a body of gelatin or other materialwhich will dissolve so as to facilitate introduction of the filaments82, and in this case these filaments 82 will be located in a' materialsuch as that used to form the implant 164 of FIG. 23, and in fact thearrangement of FIG. 23 may be used in combination with the arrangementof FIGS. 13 and 14 for the purpose of holding the filaments 82 properlyduring insertion of the implant.

According to the embodiment of the invention which is shown in FIG. 24,the tubular body organ 160 may be identical with that of FIG. 23. Afterit has been cut through for any reason, the ends may be held togetherupon closing of the tubular organ by sutures 162, as pointed out abovein connection with FIG. 23. However, in this case the implant 166 iscomposed of a cluster of particles which have an irregularconfiguration. These particles may have a shape and size similar to thatof large particles of sand, except that the particles which form thecluster 166 are made of a material which will be absorbed into the bodyupon dissolving, as is known in connection with dissolvable sutures, forexample. The body fluid flows in the direction of the arrow 168. At theright end of the cluster 166 is located a filter 170 which is made of anumber of elongated fibers of dissolvable material such as dissolvablesuture material, these fibers being pressed together so as to form thefilter 170 through which the fluid also can flow. The filter 170 isplaced by the surgeon at the location shown in FIG. 24 where it remainssimply by friction, and as a result the particles 166 are prevented fromflowing away from the region shown in FIG. 24. where they serve tosupport the interior of the tubular organ 160 against constriction dueto the formation of scar tissue. It will be noted that the cluster ofparticles 166 is distributed along the interior of the tubular organ 160through a distance which extends not only through the region where scartissue grows but also substantially beyond this region. Thus, after thetubular organ has been opened for any reason and is to be reclosed thesurgeon will introduce one portion of the cluster of particles 166 inthe right part 1600 and the other portion in the left part 160b of thetubular organ 160, as viewed in FIG. 24, so that upon closing of thetubular organ by the sutures 162, for example, the continuous cluster ofparticles 166 will be formed. Because of their size and irregularconfiguration these particles while capable of reliably supporting thetubular organ against constriction due to the growth of scar tissuenevertheless will permit the fluid to flow freely through the tubularbody organ in the direction shown by the arrow 168.

FIG. 26 illustrates yet another embodiment of an implant according tothe invention, schematically shown in FIGS. 26 in the interior of atubular body organ, while FIG. 25 schematically illustrates a stage inthe method of manufacture of the implant of FIG. 26.

Thus, referring to FIG. 25, an inner filament 172 of very fine wire orother suitable material is wound in one direction around a suitablemandrel 174 which may be made of a material such as aluminum, forexample. The fine filament 172 may be made of a springy material so thatit forms an elongated coil spring wound around the mandrel 174. Theopposed ends of the wire 172 are wrapped around inner free ends of aplurality of barbs 176 also made of any suitable metal, for example, anddistributed about the axis of the mandrel 174 as illus trated. Anydesired number of barbs 176 may be situated at each end region of thewire 172 as illustrated. ln this way the barbs 176 are held on themandrel 174 assembled with the wire 172.

Then, an outer fine filament 178, which may be identical with thematerial of the filament 172 is wound around and against the coil 172but the convolutions of the filament 178 are wound in a directionopposite to the direction of winding of the convolutions of the filament172. In this way the convolutions of the two wound filaments 172 and 178will engage each other while being inclined in opposite directions todefine a plurality of apertures. It is to be understood that thisconstruction is illustrated schematically only for the sake of clarity.Actually the windings will be located closer to each other and the pitchof the convolutions will be much sharper so that the inclination of theconvolutions will be more pronounced than illustrated. The ends of theouter wound filament 178 will also be wrapped around the inner axiallyextending ends of the barbs 176 so as to contribute to the security ofthe assembly of the components shown in FIG. 25.

This latter assembly is then placed in a suitable evacuated chamberwhere in a known way a metal, preferably gold, is vapor-deposited overthe entire assembly so as to form a coating on the exterior surfaces ofthe springy filaments 172 and 178 and the barbs 176. When using avapor-deposited material such as gold, te structure is renderedcompatible with the human body. At the same time, the part of thedeposited metal situated at the intersecting portions of the coils andbarbs serve as welds to fasten these components together at thelocations where they engage each other.

After vapor deposition has been carried out in the above manner themandrel 174, which may be made of a material such as aluminum, aspointed out above, is melted away, leaving the coated assembly of woundspringy filaments 172 and 178 together with the barbs 176. The resultingimplant 180 which iis illustrated in FIG. 26 thus includes an elongatedtubular foraminous wall constituted by the intersecting coil springfilaments 172 and 178 which are coated with a metal as described above,with this foraminous tubular wall carrying at the region of its ends thebarbs 176 which have their pointed ends directed outwardly away from theaxis of the tube and toward a central plane which is normal to the tube.

Thus, with this construction when the tubular organ 182 is cut throughfor any reason so as to have access to the interior thereof, before theends 184 of the tubular organ are again placed in engagement with eachother, the implant 180 is introduced. The barbs 176 will act in a highlyeffective manner to dig into the tissue of the tubular organ 172 so asto hold the ends 184 butting against each other to achieve healing in ahighly effective manner without the use of sutures. At the same time theforaminous wall which is constituted by the springs 172 and 178 has asufficient rigidity to oppose constriction of the lumen of the tubularorgan. It

will be noted that the length of the implant is such that it extendsthrough and substantially beyond the trauma area 186 where scar tissuewill grow. Moreover, because of the springy nature of the foraminoustubular wall it will prevent kinking of the tubular organ.

In addition, one of the great advantages achieved with this particularembodiment of the invention resides in the fact that the foraminoustubular wall constituted by the coated springs 172 and 178 itself formsa tissueingrowth means since the tissue will readily grow through andfill the tiny spaces formed between the oppositely directed coilsprings. Thus, an extremely secure joinder of the implant into the wallof the tubular organ which grows through and around the foraminous wallof the implant is achieved, so that particularly outstanding resultswill follow from this particular embodiment of the invention.

Referring to FIG. 27, there is illustrated therein an embodiment of theinvention according to which the barrier means 200 of FIG. 4 is used byitself with a vas implant since this feature need not necessarily becombined with the other features of the invention. Thus FIG. 27 shows apair of spaced vas sections 204a and 204b between which is located thecentral valve assembly 202 of a vas valve which is implanted in themanner illustrated in FIG. 27 with the elongated tubular parts 206a and20617 of the valve being covered with a suitable tissue ingrowth meansand extending along the interiors of the lumens of the vas section 204aand 2041). Thus, this arrangement is identical with that of FIG. 4except that the valve need not have the components 52. The space betweenthe vas sections 2040 and 204b is filled with the barrier means 200which is precisely the same as the barrier means 200 described above inconnection with FIG. 4. Thus with the embodiment of FIG. 27, even if itis decided not to use the elements 52 of FIG. 4, nevertheless thisembodiment will achieve the advantage of preventing the sperm frombypassing the valve along the exterior thereof since the sperm will beincapable of travelling through the thick substance 200, as describedabove in connection with FIG. 4.

It is apparent, therefore, that with the above described methods anddevices of the invention it be comes possible to carry out surgicalprocedures in such a way that the formation of scar tissue will notundesirably cause constriction of a tubular body organ, with the addedadvantages of preventing kinking of the body organ and permitting apumping action such as a peristaltic action to take place.

What is claimed is:

1. In a surgical method to be performed at the region of a tubular bodyorgan, the steps of performing surgical procedures at the region of thetubular body organ for obtaining access to the interior thereof, so thatsubsequent to the surgical procedure scar tissue will form at the latterregion during healing of tissue at said region, and introducing into thetubular body organ after access is obtained thereto by the surgicalprocedures a tubular implant which is longer than said region, theimplant having an intermediate portion for opposing constriction by scartissue which forms at said region and for performing a specific functionfor which the implant is designed and a pair of opposed elongatedflexible portions extending in opposite directions beyond theintermediate portion and while being substantially less rigid than saidintermediate portion and bendable with respect thereto also havingsufficient rigidity to support the wall of the tubular organ in theinterior thereof for opposing constriction and preventing kinking of thetubular organ in opposite directions beyond the intermediate portion ofthe implant while providing beyond the intermediate portion of theimplant in the lumen of the tubular organ a clearance sufficient topermit fluid to flow through the tubular organ, and introducing theimplant into the tubular organ with the intermediate portion thereofsituated at the region where scar tissue forms while locating saidelongated flexible portions at regions extending along the interior ofthe tubular organ in opposite directions beyond opposed ends of theintermediate portion situated at said region where scar tissue forms.

2. In a method as recited in claim 1, and wherein the tubular organ isof the type which pumps a body fluid by a contracting and expandingaction such as a peristaltic action, and situating said elongatedportions of the implant along the interior of the tubular organ in sucha way that while the tubular organ is supported by said elongatedportions of the implant the latter will not inhibit the pumping actionof the tubular organ.

3. ln a method as recited in claim 1 and including the step ofintroducing as at least part of the implant a material which is capableof being absorbed at a rate enabling the latter material to contributeto internal support of the tubular body organ opposing constrictionthereof during healing while subsequent to healing the latter materialwill dissapear.

4. In a method as recited in claim 3 and wherein the material which iscapable of being absorbed holds together parts of the implant forfacilitating introduction thereof.

5. In a method as recited in claim 3 and wherein the implant includes avalve while the tubular organ is a vas deferens, and the material whichis capable of being absorbed extends beyond the valve in oppositedirections from the area where scar tissue grows into an area where scartissue does not grow.

6. in a method as recited in claim 1 and including the step of situatingaround the exterior of the implant a means for promoting the ingrowth oftissue.

7. An implant to be introduced into a tubular organ after surgicalprocedures are performed to give access to the interior of the tubularorgan at a region along the tubular organ where scar tissue will formduring healing subsequent to the introduction of the implant into thetubular organ, said implant having a length which is greater than thelength required to occupy the interior of the tubular organ at theregion thereof where the scar tissue subsequently grows and said implantincluding elongated tubular means for permitting a body fluid to flowalong the interior of the tubular organ through the implant, saidtubular means having a rigidity sufficiently great to support thetubular organ and oppose substantial constriction thereof by the scartissues the implant further including a pair of elongated flexible meansof substantially greater flexibility than said tubular means connectedwith and extending in opposite directions beyond opposed ends of saidtubular means for extending therefrom respectively beyond said opposedends into regions of the tubular organ beyond the region where scartissue subsequently grows, said pair of elongated flexible means whilebeing bendable never theless having sufficient rigidity to support thewall of the tubular organ and permit curving thereof without kinking atregions beyond the region where scar tissue subsequently grows, and saidpair of flexible means each having a cross section adapted to occupyonly part of the cross section of the lumen of the tubular organ forleaving therein a clearance extending longitudinally along the lumensufficiently great for fluid to flow therethrough. i

8. An implant as recited in claim 7 and wherein said implant carries atits exterior a means for promoting the ingrowth of tissue.

9. An implant as recited in claim 7 and wherein the pair of elongatedmeans support the tubular organ while permitting contraction andexpansion thereof so that the tubular organ can carry out a pumpingaction.

10. An implant as recited in claim 9 and wherein each of the elongatedmeans has at least a pair of opposed edge regions for engaging theinterior surface of the tubular organ while leaving on opposite sides ofeach edge region free spaces in the tubular organ.

11. An implant as recited in claim 10 and wherein each of said elongatedmeans has the configuration of an elongated strip.

12. An implant as recited in claim 10 and wherein each of the elongatedmeans has a central region extending centrally along the interior of thetubular organ and a plurality of ribs projecting from the central regionand having the edge regions which engage the inner surface of thetubular organ.

13. An implant as recited in claim 10 and wherein each elongated meansis of a V-shaped cross section.

14. An implant as recited in claim 9 and wherein each of said elongatedmeans is made of a flexible material of a substantially U-shaped crosssection.

15. An implant as recited in claim 9 and wherein each of said elongatedmeans is made of a flexible material having a substantiallyspiral-shaped cross section.

16. An implant as recited in claim 9 and wherein each of said elongatedmeans is in the form of a plurality of elongated filaments extendingfrom said tubular portions and free to move inwardly toward and outwardly away from each other.

17. The combination of claim 7 and wherein the implant is in the form ofa control means adapted to be introduced into a tubular organ for actingon fluid therein, said control means having a central control region anda pair of elongated tubular portions extending in opposite directionsfrom said central control region and having a length great enough toextend through and beyond a region where scar tissue will form into aregion where scar tissue will not form, each of said tubular portionshaving along at least part of its length a section which is flexible toenable the tubular organ to bend, so as to prevent kinking thereof,while at the same time capable of opposing constriction of the tubularorgan during healing thereof.

18. The combination of claim 17 and wherein the flexible sections ofsaid tubular portions are respectively situated next to the centralregion.

19. The combination of claim 7 and wherein said implant includes aflexible tubular wall extending along the entire length of the implant.

20. The combination of claim 17 and wherein said flexible section ofeach tubular portion is in the form of a series of convolutions.

21. The combination of claim 17 and wherein the flexible section of eachtubular portion is situated at an outer end region thereof distant fromthe central control region.

bular portion which extends beyond its solid wall portion.

24.The combination of claim 17 and wherein the flexible sections of saidtubular portions are respectively in the form of elongated tapered freeend portions of each tubular portion situated distant from the centralcontrol region and having a tapered as well as a convolutedconfiguration.

1. In a surgical method to be performed at the region of a tubular bodyorgan, the steps of performing surgical procedures at the region of thetubular body organ for obtaining access to the interior thereof, so thatsubsequent to the surgical procedure scar tissue will form at the latterregion during healing of tissue at said region, and introducing into thetubular body organ after access is obtained thereto by the surgicalprocedures a tubular implant which is longer than said region, theimplant having an intermediate portion for opposing constriction by scartissue which forms at said region and for performing a specific functionfor which the implant is designed and a pair of opposed elongatedflexible portions extending in opposite directions beyond theintermediate portion and while being substantially less rigid than saidintermediate portion and bendable with respect thereto also havingsufficient rigidity to support the wall of the tubular organ in theinterior thereof for opposing constriction and preventing kinking of thetubular organ in opposite directions beyond the intermediate portion ofthe implant while providing beyond the intermediate portion of theimplant in the lumen of the tubular organ a clearance sufficient topermit fluid to flow through the tubular organ, and introducing theimplant into the tubular organ with the intermediate portion thereofsituated at the region where scar tissue forms while locating saidelongated flexible portions at regions extending along the interior ofthe tubular organ in opposite directions beyond opposed ends of theintermediate portion situated at said region where scar tissue forms. 2.In a method as recited in claim 1, and wherein the tubular organ is ofthe type which pumps a body fluid by a contracting and expanding actionsuch as a peristaltic action, and situating said elongated portions ofthe implant along the interior of the tubular organ in such a way thatwhile the tubular organ is supported by said elongated portions of theimplant the latter will not inhibit the pumping action of the tubularorgan.
 3. In a method as recited in claim 1 and including the step ofintroducing as at least part of the implant a material which is capableof being absorbed at a rate enabling the latter material to contributeto internal support of the tubular body organ opposing constrictionthereof during healing while subsequent to healing the latter materialwill dissapear.
 4. In a method as recited in claim 3 and wherein thematerial which is capable of being absorbed holds together parts of theimplant for facilitating introduction thereof.
 5. In a method as recitedin claim 3 and wherein the implant includes a valve while the tubularorgan is a vas deferens, and the material which is capable of beingabsorbed extends beyond the valve in opposite directions from the areawhere scar tissue grows into an area where scar tissue does not grow. 6.In a method as recited in claim 1 and including the step of situatingaround the exterior of the implant a means for promoting the ingrowth oftissue.
 7. An implant to be introduced into a tubular organ aftersurgical procedures are performed to give access to the interior of thetubular organ at a region along the tubular organ where scar tissue willform during healing subsequent to the introduction of the implant intothe tubular organ, said implant having a length which is greater thanthe length required to occupy the interior of the tubular organ at theregion thereof where the scar tissue subsequently grows and said implantincluding elongated tubular means for permitting a body fluid to flowalong the interior of the tubular organ through the implant, saidtubular means having a rigidity sufficiently great to support thetubular organ and oppose substantial constriction thereof by the scartissues the implant further including a pair of elongated flexible meansof substantially greater flexibility than said tubular means connectedwith and extending in opposite directions beyond opposed ends of saidtubular means for extending therefrom respectively beyond said opposedends into regions of the tubular organ beyond the region where scartissue subsequently grows, said pair of elongated flexible means whilebeing bendable nevertheless having sufficient rigidity to support thewall of the tubular organ and permit curving thereof without kinking atregions beyond the region where scar tissue subsequently grows, and saidpair of flexible means each having a cross section adapted to occupyonly part of the cross section of the lumen of the tubular organ forleaving therein a clearance extending longitudinally along the lumensufficiently great for fluid to flow therethrough.
 8. An implant asrecited in claim 7 and wherein said implant carries at its exterior ameans for promoting the ingrowth of tissue.
 9. An implant as recited inclaim 7 and wherein the pair of elongated means support the tubularorgan while permitting contraction and expansion thereof so that thetubular organ can carry out a pumping action.
 10. An implant as recitedin claim 9 and wherein each of the elongated means has at least a pairof opposed edge regions for engaging the interior surface of the tubularorgan while leaving on opposite sides of each edge region free spaces inthe tubular organ.
 11. An implant as recited in clAim 10 and whereineach of said elongated means has the configuration of an elongatedstrip.
 12. An implant as recited in claim 10 and wherein each of theelongated means has a central region extending centrally along theinterior of the tubular organ and a plurality of ribs projecting fromthe central region and having the edge regions which engage the innersurface of the tubular organ.
 13. An implant as recited in claim 10 andwherein each elongated means is of a V-shaped cross section.
 14. Animplant as recited in claim 9 and wherein each of said elongated meansis made of a flexible material of a substantially U-shaped crosssection.
 15. An implant as recited in claim 9 and wherein each of saidelongated means is made of a flexible material having a substantiallyspiral-shaped cross section.
 16. An implant as recited in claim 9 andwherein each of said elongated means is in the form of a plurality ofelongated filaments extending from said tubular portions and free tomove inwardly toward and outwardly away from each other.
 17. Thecombination of claim 7 and wherein the implant is in the form of acontrol means adapted to be introduced into a tubular organ for actingon fluid therein, said control means having a central control region anda pair of elongated tubular portions extending in opposite directionsfrom said central control region and having a length great enough toextend through and beyond a region where scar tissue will form into aregion where scar tissue will not form, each of said tubular portionshaving along at least part of its length a section which is flexible toenable the tubular organ to bend, so as to prevent kinking thereof,while at the same time capable of opposing constriction of the tubularorgan during healing thereof.
 18. The combination of claim 17 andwherein the flexible sections of said tubular portions are respectivelysituated next to the central region.
 19. The combination of claim 7 andwherein said implant includes a flexible tubular wall extending alongthe entire length of the implant.
 20. The combination of claim 17 andwherein said flexible section of each tubular portion is in the form ofa series of convolutions.
 21. The combination of claim 17 and whereinthe flexible section of each tubular portion is situated at an outer endregion thereof distant from the central control region.
 22. Thecombination of claim 17 and wherein the flexible sections of saidtubular portion are each in the form of coil springs fixed to andextending from the remainder of the tubular portions.
 23. Thecombination of claim 17 and wherein each tubular portion has a solidwall portion next to the central control region and beyond said solidwall portion an elongated free end portion which is cut through along aspiral to form a spring from the part of each tubular portion whichextends beyond its solid wall portion.
 24. The combination of claim 17and wherein the flexible sections of said tubular portions arerespectively in the form of elongated tapered free end portions of eachtubular portion situated distant from the central control region andhaving a tapered as well as a convoluted configuration.